January 19, 2018: New Research Methods Resources Website on Group- or Cluster-Randomized Studies

The National Institutes of Health (NIH) Office of Extramural Research has released new clinical trial requirements for grant applications and contract proposals due on or after January 25, 2018. In anticipation of these new requirements, the NIH modified the Application Guide and the Review Criteria to address methodological problems common to many clinical trials. As group- or cluster-randomization designs are increasingly common in both basic and applied research, the new Application Guide includes links to the new Research Methods Resources website, which provides resources for investigators considering these group- or cluster-randomized designs, including lists of NIH webinars, key references, and statements to help investigators prepare sound applications and avoid methodological pitfalls.

January 18, 2018: Implementation of Revised Common Rule Delayed

On January 17, 2018, the Department of Health and Human Services and 15 other federal departments and agencies announced a delay to both the effective and compliance dates for the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule). Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. The Interim Final Rule announced a delay until July 19, 2018, with the option for further delay, to give institutions additional time to prepare to implement the revisions. Before July 19, 2018, institutions may only begin implementing provisions of the revised Common Rule that do not conflict with the pre-2018 Common Rule.

A notice of proposed rulemaking (NPRM) is also in development to seek public comment on a proposal for further delay in the required implementation of the revised Common Rule (for example, until January 21, 2019). A decision will be made after considering public comments.

January 17, 2018: The “All of Us” Research Program Asks for Research Ideas

The groundbreaking “All of Us” research program, which aims to enroll and track more than a million people, is asking prospective researchers, community organizations, and citizen scientists for suggestions regarding potential research questions. Ideas can be submitted through a special research page and are due by February 19, 2018. At a Research Priorities Workshop in March 2018, meeting attendees will use the input to set research priorities that will drive the development of the All of Us research platform and associated tools.

January 10, 2018: NCI Announces Training Institute in Dissemination and Implementation Research in Cancer

The National Cancer Institute’s Division of Cancer Control & Population Sciences is accepting applications for a Training Institute in Dissemination and Implementation Research in Cancer (TIDIRC). Designed for investigators at all levels who conduct dissemination and implementation research in cancer control, the training institute will consist of a 4-month online course and a 2-day in-person training.

There are no costs associated with the training institute, though applicants who are accepted into the program must cover travel-related expenses for the in-person meeting in Bethesda, Maryland.

This cancer-focused training program is adapted from a broader curriculum offered in previous years, the Training Institute in Dissemination and Implementation Research in Health (TIDIRH). Read an article in Implementation Science about the development of the program: “The U.S. Training Institute for Dissemination and Implementation Research in Health.”

The application window for the training institute will close on February 9, 2018. Read the announcement and submit an application: https://cancercontrol.cancer.gov/IS/training-education/tidirc/index.html.

January 10, 2018: New Podcast: Drs. Richard Platt and Christopher Granger discuss IMPACT-AFib and the Role of Sentinel

The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Richard Platt of Harvard Pilgrim Health Care Institute and Dr. Christopher Granger of Duke University. In this episode, Drs. Platt and Granger speak with moderator Dr. Adrian Hernandez about the IMPACT-AFib atrial fibrillation trial and the role of the FDA’s Sentinel Inititative in leveraging pharmacy data to find eligible participants.

Listen to the episode here:

At least once a month, we will release interviews with Grand Rounds speakers that delve into their topic of interest and give listeners bonus time with these featured experts.

Please let us know what you think by providing your feedback through the podcast page. We also encourage you to listen and share the recordings with your colleagues!

December 18, 2017: New Podcast: Drs. Greg Simon and Susan Ellenberg Discuss Data and Safety Monitoring in Pragmatic Trials

The NIH Collaboratory is pleased to announce that the new episode of the Grand Rounds podcast is now available, featuring Dr. Greg Simon, principal investigator on the Suicide Prevention Outreach Trial (SPOT), and Dr. Susan Ellenberg of the Regulatory/Ethics Core. In this episode, Drs. Simon and Ellenberg discuss the need for a data and safety monitoring plan in any clinical trial, and specifically when a Data and Safety Monitoring Board (DSMB) might be needed in a pragmatic trial.

Listen to the episode here:

At least once a month, we will release interviews with Grand Rounds speakers that delve into their topic of interest and give listeners bonus time with these featured experts.

Please let us know what you think by providing your feedback through the podcast page. We also encourage you to listen and share the recordings with your colleagues!

December 14, 2017: NIH Encourages Authors to Publish in Reputable Journals

Publication in journals is an essential part of the scientific process, an important metric for scholarly career advancement, and an integral aspect of grant approval and funding mechanisms. Pressure to publish has engendered a global industry of open access journals, which are driven by author publication fees rather than subscription services. Some of these journals are not credible and are considered predatory; they may have misleading pricing, fraudulent editorial boards, and inadequate (or nonexistent) peer-review processes.

To help ensure the credibility of published research, the NIH released a statement on publication in scientific journals (NOT-OD-18-011).

“In support of public access to National Institutes of Health (NIH) funded research, authors are encouraged to publish their results in reputable journals. The NIH has noted an increase in the numbers of papers reported as products of NIH funding which are published in journals or by publishers that do not follow best practices promoted by professional scholarly publishing organizations.”

There are a number of resources available to authors to help identify reputable journals:

For more information on disseminating results from pragmatic clinical trials see the Living Textbook Chapters:

December 12, 2017: NIH Collaboratory Core Working Group Interviews: Reflections from the Patient-Reported Outcomes Core

We recently asked Dr. Kevin Weinfurt, Chair of the Patient-Reported Outcomes (PRO) Core, to reflect on the first 5 years of the Core’s work and the challenges ahead. He says the biggest impact of the Core has been working with national initiatives to improve inclusion of PROs in the electronic health record (EHR). Further, Core members have contributed to new knowledge through white papers and chapters in the Living Textbook. In the coming years, he’s hoping the Core will be able to identify the value proposition of PROs.

“Because there are costs associated with collecting PROs, we need to determine when PROS are essential, supporting, or not at all informative for the clinical questions. This gets at the value proposition: When are they of value and to whom?” —Dr. Kevin Weinfurt.

Read more from Dr. Weinfurt in the full interview (pdf).

December 7, 2017: Dr. Greg Simon Explains Individual, Cluster, and Stepped-Wedge Randomization in a New Prop Video

In a new video in the Living Textbook, Dr. Greg Simon describes the differences between individual, cluster, and stepped-wedge randomization using props, including marbles, Play-Doh, and glassware.

“In the end, it’s all about randomly assigning who gets which treatment, or who gets which treatment when, so that we’re able to make some un-biased judgement about which treatment is really better.” —Greg Simon, MD

December 5, 2017: Dr. Greg Simon Answers the Question: What is a Pragmatic Trial?

In a new video for the Living Textbook, Dr. Greg Simon uses props—including Play-Doh and toys—to define pragmatic trials and their importance in clinical research.

“Pragmatic clinical trials are about helping doctors make better decisions to take care of their patients.” —Greg Simon, MD